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Compendial Approvals for USP38-NF33 2S
Category Monograph Title Monograph Section Scientific Liaison
Revision <31> VOLUMETRIC APPARATUS PF 40(4) Pg. ONLINE
USE, STANDARDS OF ACCURACY Horacio Pappa
Revision <111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS PF 40(4) Pg. ONLINE
General, STEPS PRECEDING THE CALCULATION OF POTENCY, CALCULATION OF POTENCY FROM A SINGLE ASSAY, EXPERIMENTAL ERROR AND TESTS OF ASSAY VALIDITY, THE CONFIDENCE INTERVAL AND LIMITS OF POTENCY, COMBINATION OF INDEPENDENT ASSAYS, JOINT ASSAY OF SEVERAL PREPARATIONS, GLOSSARY, INTRODUCTION, REJECTION OF OUTLYING OR ABERRANT OBSERVATIONS, APPENDIX-KEY LITERATURE
Maura Kibbey
New <212> OLIGOSACCHARIDE ANALYSIS PF 40(3) Pg. ONLINE
INTRODUCTION/Introduction, INTRODUCTION/ANALYTICAL PROCEDURES OVERVIEW, INTRODUCTION/SAMPLE PREPARATION, INTRODUCTION/SEPARATION AND IDENTIFICATION OF OLIGOSACCHARIDES, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>, ADDITIONAL REQUIREMENTS/APPENDIX I
Edith Chang
Revision <232> ELEMENTAL IMPURITIES--LIMITS PF 40(2) Pg. ONLINE
INTRODUCTION, ROUTES OF EXPOSURE, DRUG PRODUCTS, DRUG SUBSTANCE AND EXCIPIENTS, ANALYTICAL TESTING
Kahkashan Zaidi
Revision <233> ELEMENTAL IMPURITIES - PROCEDURES PF 40(2) Pg. ONLINE
INTRODUCTION, COMPENDIAL PROCEDURES 1 AND 2, REQUIREMENTS FOR ALTERNATE PROCEDURE VALIDATION, LIMIT PROCEDURES, QUANTITATIVE PROCEDURES, APPENDIX
Kahkashan Zaidi
Revision <561> ARTICLES OF BOTANICAL ORIGIN PF 40(5) Pg. ONLINE
GENERAL METHOD FOR PESTICIDE RESIDUESRESIDUE ANALYSIS, TEST FOR PESTICIDES, LIMITS OF ELEMENTAL IMPURITIES
Christopher Okunji
Revision <565> BOTANICAL EXTRACTS PF 40(5) Pg. ONLINE
PREPARATIONS Christopher Okunji
Revision <755> MINIMUM FILL PF 40(4) Pg. ONLINE
Introduction, SCOPE, PURPOSE, PROCEDURE FOR DOSAGE FORMS OTHER THAN AEROSOLS, PROCEDURE FOR DOSAGE FORMS OTHER THAN AEROSOLS-, ACCEPTANCE CRITERIA
William Brown
New <1025> PANCREATIN PF 40(5) Pg. ONLINE
OUTLINE, 1. INTRODUCTION, 2. PANCREAS COLLECTION AND PANCREATIN PRODUCTION, 3. QUALITY CONTROL, 4. LABELING, 5. CERTIFICATION AND DOCUMENTATION, 6. TESTING AND CONTROL OF ADVENTITIOUS INFECTIOUS AGENTS, 7. CHARACTERIZATION OF PANCREATIN, 8. ENZYME ACTIVITY MEASUREMENTS, APPENDIX 1: REGULATORY BIBLIOGRAPHY, APPENDIX 2: LITERATURE BIBLIOGRAPHY
Edith Chang
New
<1132>RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS PF 40(4) Pg. ONLINE
1. INTRODUCTION AND SCOPE, 2. TERMINOLOGY, 3. HCP IMMUNOASSAY METHODS, 4. HCP IMMUNOASSAY METHOD VALIDATION, 5. SUPPORTING TECHNOLOGIES FOR RESIDUAL HCP DETECTION, IDENTIFICATION, AND MEASUREMENT, 6. USE OF HCP IMMUNOASSAYS FOR PROCESS DEVELOPMENT, CHARACTERIZATION, AND VALIDATION, 7. SUMMARY AND
Maura Kibbey
CONCLUSIONS, 8. BIBLIOGRAPHY
Revision <1223> VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS PF 40(4) Pg. ONLINE
INTRODUCTION, TYPES OF MICROBIOLOGICAL TESTS, VALIDATION OF QUALITATIVE TESTS FOR DEMONSTRATION OF VIABLE MICROORGANISMS IN A SAMPLE, VALIDATION OF QUANTITATIVE ESTIMATION OF VIABLE MICROORGANISMS IN A SAMPLE, INTRODUCTION, USER REQUIREMENTS, INSTRUMENT QUALIFICATION, VALIDATION OF ALTERNATE TECHNOLOGIES, METHOD SUITABILITY, EQUIVALENCY, GLOSSARY, REFERENCES
Radhakrishna Tirumalai
New
<1223.1> VALIDATION OF ALTERNATIVE METHODS TO ANTIBIOTIC MICROBIAL ASSAYS PF 40(4) Pg. ONLINE
INTRODUCTION, GENERAL CONSIDERATIONS FOR ALTERNATIVE METHOD DEVELOPMENT, APPENDIX 1: TOST FORMULAS FOR INDEPENDENT SAMPLES, APPENDIX 2: TOST FORMULAS FOR PAIRED SAMPLES, APPENDIX 3: BLAND-ALTMAN PLOTS, REFERENCES
Radhakrishna Tirumalai
Omission
CAPSULES CONTAINING AT LEAST THREE OF THE FOLLOWING--ACETAMINOPHEN AND SALTS OF CHLORPHENIRAMINE, DEXTROMETHORPHAN, AND PHENYLPROPANOLAMINE PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Omission
ORAL SOLUTION CONTAINING AT LEAST THREE OF THE FOLLOWING--ACETAMINOPHEN AND SALTS OF CHLORPHENIRAMINE,
DEXTROMETHORPHAN, AND PHENYLPROPANOLAMINE PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Omission
TABLETS CONTAINING AT LEAST THREE OF THE FOLLOWING--ACETAMINOPHEN AND SALTS OF CHLORPHENIRAMINE, DEXTROMETHORPHAN, AND PHENYLPROPANOLAMINE PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Revision ALCOHOL Stage 6 Harmonization Entire Document Jenny Liu
Revision DEHYDRATED ALCOHOL Stage 6 Harmonization
Entire Document Jenny Liu
Revision AMERICAN GINSENG PF 40(5) Pg. ONLINE
COMPOSITION/Content of Ginsenosides, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED AMERICAN GINSENG PF 40(5) Pg. ONLINE
COMPOSITION/Content of Ginsenosides, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of
Anton Bzhelyansky
Elemental Impurities <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>
New AMLODIPINE AND VALSARTAN TABLETS PF 40(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Besylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Valsartan RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Valsartan Related Compound B RS
Sujatha Ramakrishna
Revision ANDROGRAPHIS PF 40(5) Pg. ONLINE IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED ANDROGRAPHIS PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision ANETHOLE PF 40(1) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197F>, IDENTIFICATION/B. Chromatographic Identity, ASSAY/Assay for trans-Anethole, IMPURITIES/Limit of cis-Anethole, p-Anisaldehyde, and Other Volatile Impurities, IMPURITIES/Aldehydes and Ketones, SPECIFIC TESTS/Congealing Temperature <651>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Galina Holloway
Revision ASHWAGANDHA ROOT PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED ASHWAGANDHA ROOT PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision ASIAN GINSENG PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED ASIAN GINSENG PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561>
Anton Bzhelyansky
Revision ASPARTAME PF 40(4) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Limit of 5-Benzyl-3,6-dioxo-2-piperazineacetic Acid, IMPURITIES/Chromatographic Purity, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP l-Phenylalanine RS
Galina Holloway
Revision ASPARTIC ACID PF 40(4) Pg. ONLINE
IMPURITIES/Chromatographic Purity, IMPURITIES/Related Compounds, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fumaric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Maleic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Malic Acid RS
Huy Dinh
Revision AZATADINE MALEATE PF 40(4) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities Domenick Vicchio
Revision AZTEC MARIGOLD ZEAXANTHIN EXTRACT PF 40(5) Pg. ONLINE
DEFINITION/Introduction, COMPOSITION/Lutein and Other Related Compounds, CONTAMINANTS/Heavy Metals, Method II <231>, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Residue on Ignition <281>
Huy Dinh
Revision BACOPA PF 40(5) Pg. ONLINE IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED BACOPA PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
New BECLOMETHASONE DIPROPIONATE COMPOUNDED ORAL SOLUTION PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Beclomethasone Dipropionate RS
Jeanne Sun
Revision BENZOCAINE TOPICAL AEROSOL PF 40(4) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Other Requirements, SPECIFIC TESTS/Topical Aerosols, Pressure Test <603>, SPECIFIC TESTS/Leak Rate <604>, SPECIFIC TESTS/Minimum Fill <755>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Ravi Ravichandran
Revision BENZOCAINE OINTMENT PF 40(2) Pg. ONLINE
IDENTIFICATION/A. Ointments Having Water-Soluble Bases, IDENTIFICATION/A., IDENTIFICATION/B. Ointments Having Water-Insoluble Bases, IDENTIFICATION/B., ASSAY/Ointments Having Water-
Soluble Bases, ASSAY/Ointments Having Water-Insoluble Bases, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Domenick Vicchio
Revision BENZOCAINE TOPICAL SOLUTION PF 40(4) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Domenick Vicchio
Revision BLACK COHOSH PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED BLACK COHOSH PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision BLACK PEPPER PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>, SPECIFIC TESTS/Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 1 <561>, SPECIFIC TESTS/Articles of Botanical Origin, Water-Soluble Extractives, Method 1 <561>
Anton Bzhelyansky
Revision POWDERED BLACK PEPPER PF 40(5) CONTAMINANTS/Heavy Metals, Method III <231>, Anton Bzhelyansky
Pg. ONLINE CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Revision BOSWELLIA SERRATA PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision BUPROPION HYDROCHLORIDE PF 39(4) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Limit of m-Chlorobenzoic Acid, IMPURITIES/Limit of 3-Chlorobenzoic Acid, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupropion Hydrochloride Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupropion Hydrochloride Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 3-Chlorobenzoic Acid RS
Heather Joyce
Revision BUTYLATED HYDROXYTOLUENE PF 40(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Congealing Temperature <651>
Galina Holloway
Revision CABERGOLINE PF 40(5) Pg. ONLINE IDENTIFICATION/B. Heather Joyce
Revision CALCIUM WITH VITAMIN D TABLETS PF 40(5) Pg. ONLINE
CONTAMINANTS/Microbiological Procedures for Absence of Specified Microorganisms <2022>
Natalia Davydova
Revision CALCIUM AND VITAMIN D WITH MINERALS TABLETS PF 40(5) Pg. ONLINE
SPECIFIC TESTS/Absence of Specified Microorganisms-Nutritional and Dietary Supplements <2022>
Natalia Davydova
Revision CARBACHOL PF 40(5) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466> Heather Joyce
Revision CARBAMAZEPINE PF 40(4) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities Heather Joyce
Revision CARBAMAZEPINE ORAL SUSPENSION PF 40(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities,
ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbamazepine Related Compound B RS
Heather Joyce
Revision CARBAMAZEPINE TABLETS PF 40(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method III <921>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Carbamazepine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 9-Methylacridine RS
Heather Joyce
Revision CARBOPROST TROMETHAMINE PF 40(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of 15R-Epimer and 5-trans Isomer, IMPURITIES/Organic Impurities
Domenick Vicchio
Revision CAT'S CLAW PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED CAT'S CLAW PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision CENTELLA ASIATICA PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED CENTELLA ASIATICA PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision CETOSTEARYL ALCOHOL PF 40(2) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Related Fatty Alcohols, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Arachidyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauryl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linolenyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Myristyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleyl Alcohol RS
Galina Holloway
Revision CETYL ALCOHOL PF 40(1) Pg. ONLINE
Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Related Fatty Alcohols, SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Labeling,
ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauryl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Myristyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleyl Alcohol RS
Galina Holloway
Revision CHASTE TREE PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED CHASTE TREE PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561>
Anton Bzhelyansky
Revision HORSE CHESTNUT PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED HORSE CHESTNUT PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Omission
CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Omission
CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PF 40(5) Pg. ONLINE
Entire document Hillary Cai
New CISAPRIDE COMPOUNDED INJECTION, VETERINARY PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Particulate Matter in Injections <788>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Standard <11>/USP Cisapride RS, ADDITIONAL REQUIREMENTS/USP Reference Standard <11>/USP Endotoxin RS
Jeanne Sun
New CISAPRIDE COMPOUNDED ORAL SUSPENSION, VETERINARY PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cisapride RS
Jeanne Sun
Revision CLEMASTINE FUMARATE PF 40(5) Pg. ONLINE
IDENTIFICATION/B. Thin Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Clarity and Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Chlorobenzophenone RS
Domenick Vicchio
Revision CLOFAZIMINE PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197S>, IDENTIFICATION/A. Infrared Absorption <197>,
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clofazimine Related Compound B RS
Shankari Shivaprasad
Revision CLOFAZIMINE CAPSULES PF 40(5) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clofazimine Related Compound B RS
Shankari Shivaprasad
Revision CLOMIPHENE CITRATE PF 40(5) Pg. ONLINE
IDENTIFICATION/Identification-Organic Nitrogenous Bases <181>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage
Domenick Vicchio
Revision COPPER GLUCONATE PF 40(5) Pg. ONLINE
IMPURITIES/Limit of Lead Huy Dinh
Revision CORTICOTROPIN INJECTION PF 40(5) Pg. ONLINE
Chemical Info, IDENTIFICATION/A. HPLC, IDENTIFICATION/B., ASSAY/Procedure
Maura Kibbey
Revision CORTICOTROPIN FOR INJECTION PF 40(5) Pg. ONLINE
Chemical Info, IDENTIFICATION/A. HPLC, IDENTIFICATION/B., ASSAY/Procedure
Maura Kibbey
Revision REPOSITORY CORTICOTROPIN INJECTION PF 40(5) Pg. ONLINE
Chemical Info, IDENTIFICATION/A., ASSAY/Procedure Maura Kibbey
Revision CRYPTHECODINIUM COHNII OIL PF 40(5) Pg. ONLINE
IMPURITIES/Inorganic Impurities, IMPURITIES/Limit of Lead Huy Dinh
Revision CRYPTHECODINIUM COHNII OIL CAPSULES PF 40(5) Pg. ONLINE
IMPURITIES/Limit of Lead Natalia Davydova
New CYCLOSPORINE COMPOUNDED OPHTHALMIC SOLUTION, VETERINARY PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Particulate Matter in Ophthalmic Solutions <789>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cyclosporine RS
Jeanne Sun
Revision DESCRIPTION AND SOLUBILITY PF 40(2) Pg. ONLINE
Levocetirizine Dihydrochloride, Tolterodine Tartrate, Ezetimibe Mary Koleck
Revision DESMOPRESSIN ACETATE PF 40(5) Pg. ONLINE
IDENTIFICATION/A. Mass Spectral Analysis, IDENTIFICATION/B., IDENTIFICATION/C. Amino acid content, ASSAY/Procedure, IMPURITIES/Desmopressin-Related Impurities, OTHER COMPONENTS/Acetic Acid In Peptides <503>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS
Anita Szajek
Revision DEXAMETHASONE SODIUM PHOSPHATE PF 40(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Thin Layer Chromatography, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., IDENTIFICATION/B. Identification Tests-General, Phosphate <191>, IDENTIFICATION/C. Identification Tests-General,
Sodium <191>, ASSAY/Procedure, IMPURITIES/Limit of Phosphate Ions, IMPURITIES/Limit of Alcohol, IMPURITIES/Limit of Free Dexamethasone, IMPURITIES/Chromatographic Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Acetonitrile RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Betamethasone Sodium Phosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dexamethasone Sodium Phosphate RS
Domenick Vicchio
Revision DOXORUBICIN HYDROCHLORIDE PF 40(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption <197K>, IDENTIFICATION/C. Identification Tests-General, Chloride <191>, ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2: Limit of Solvent Residues (as Acetone and Alcohol), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Daunorubicin Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Daunorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference
Ahalya Wise
Standards <11>/USP Doxorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epirubicin Hydrochloride RS
Revision DOXORUBICIN HYDROCHLORIDE INJECTION PF 40(3) Pg. ONLINE
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Daunorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epirubicin Hydrochloride RS
Ahalya Wise
Revision DOXORUBICIN HYDROCHLORIDE FOR INJECTION PF 40(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Daunorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxorubicinone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Epirubicin Hydrochloride RS
Ahalya Wise
Revision ECONAZOLE NITRATE PF 40(2) Pg. ONLINE
24169-02-6Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Econazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Econazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Econazole Related Compound C RS
Shankari Shivaprasad
Revision EDETATE CALCIUM DISODIUM Stage 6 Harmonization
Entire Document Jenny Liu
Revision ELEUTHERO PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED ELEUTHERO PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
New ENROFLOXACIN COMPOUNDED ORAL SUSPENSION, VETERINARY PF 39(4) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Enrofloxacin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Enrofloxacin Related Compound Mixture RS
Jeanne Sun
New 15-EPICARBOPROST PF 40(3) Pg. ONLINE
15-Epicarboprost Ravi Ravichandran
New EVENING PRIMROSE OIL CAPSULES PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Fatty Acid Profile, STRENGTH/Content of γ-Linolenic, Linoleic, and Oleic Acids,
Natalia Davydova
PERFORMANCE TESTS/Disintegration and Dissolution <2040>, PERFORMANCE TESTS/Weight Variation <2091>, SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Evening Primrose Oil RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Linoleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Linolenate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Oleate RS
New EZETIMIBE PF 40(5) Pg. ONLINE
Chemical Info/Chemical Structure, Chemical Info/(C24H21F2NO3), Chemical Info/409.43, Chemical Info/2-Azetidinone, 1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-, [3R-[3α(S*),4β]]-;, Chemical Info/(3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone;, Chemical Info/(3R,4S)-1-(4-Fluorophenyl)-3-[(S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-azetidin-2-one, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, SPECIFIC TESTS/Water Determination, Method Ia <921>, SPECIFIC TESTS/Optical
Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ezetimibe RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ezetimibe System Suitability Mixture RS
Sujatha Ramakrishna
New EZETIMIBE TABLETS PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ezetimibe RS
Sujatha Ramakrishna
New FAMCICLOVIR COMPOUNDED ORAL SUSPENSION PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Famciclovir RS
Jeanne Sun
New FENUGREEK SEED PF 39(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatography-Amino Acid Profile, IDENTIFICATION/B. Thin-Layer Chromatography-Steroidal Saponins Profile, COMPOSITION/Content of 4-Hydroxyisoleucine, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration
Anton Bzhelyansky
Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, SPECIFIC TESTS/Presence of Trigonelline, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin, Foreign Organic Matter <561>, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin, Total Ash <561>, SPECIFIC TESTS/Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 1  <561>, SPECIFIC TESTS/Articles of Botanical Origin, Water-Soluble Extractives, Method 1  <561>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Hydroxyisoleucine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trigonella Foenum-graecum Seed Powdered Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trigonelline Hydrochloride RS
New FENUGREEK SEED POWDER PF 39(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatography-Amino Acid Profile, IDENTIFICATION/B. Thin-Layer Chromatography-Steroidal Saponins Profile, COMPOSITION/Content of 4-Hydroxyisoleucine, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, SPECIFIC TESTS/Presence of Trigonelline, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical
Origin, Foreign Organic Matter <561>, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin, Total Ash <561>, SPECIFIC TESTS/Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 1 <561>, SPECIFIC TESTS/Articles of Botanical Origin, Water-Soluble Extractives, Method 1 <561>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 4-Hydroxyisoleucine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trigonella Foenum-graecum Seed Powdered Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trigonelline Hydrochloride RS
Anton Bzhelyansky
New FENUGREEK SEED POWDERED EXTRACT PF 39(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatography-Amino Acid Profile, IDENTIFICATION/B. Thin-Layer Chromatography-Steroidal Saponins Profile, COMPOSITION/Content of 4-Hydroxyisoleucine, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, SPECIFIC TESTS/Presence of Trigonelline, SPECIFIC TESTS/Water Determination, Method Ia <921>, SPECIFIC TESTS/Residue on Ignition <281>, SPECIFIC TESTS/Residual Solvents <565>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference
Anton Bzhelyansky
Standards <11>/USP 4-Hydroxyisoleucine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trigonella Foenum-graecum Seed Powdered Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Trigonelline Hydrochloride RS
Revision FERROUS FUMARATE PF 40(5) Pg. ONLINE
IMPURITIES/Limit of Lead Huy Dinh
Revision FERROUS GLUCONATE PF 40(5) Pg. ONLINE
IMPURITIES/Limit of Lead Huy Dinh
Revision FERROUS SULFATE PF 40(5) Pg. ONLINE
IMPURITIES/Lead Huy Dinh
Revision DRIED FERROUS SULFATE PF 40(5) Pg. ONLINE
IMPURITIES/Limit of Lead Huy Dinh
Revision FEVERFEW PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED FEVERFEW PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision FISH OIL CONTAINING OMEGA-3 ACIDS CAPSULES PF 40(5) Pg. ONLINE
CONTAMINANTS/Limit of Lead Natalia Davydova
Revision FISH OIL CONTAINING OMEGA-3 ACIDS PF 40(5) Pg. ONLINE
CONTAMINANTS/Limit of Lead Huy Dinh
Revision FLUOXETINE DELAYED-RELEASE CAPSULES PF 40(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Drug release Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Related
Compound C RS
Heather Joyce
Revision FLUOXETINE TABLETS PF 40(4) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluoxetine Related Compound B RS
Heather Joyce
Revision FORSKOHLII PF 40(5) Pg. ONLINE IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED FORSKOHLII PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GARCINIA CAMBOGIA PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED GARCINIA CAMBOGIA PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GARCINIA INDICA PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED GARCINIA INDICA PF 40(5) Pg. ONLINE
IMPURITIES/Heavy Metals, Method III <231>, IMPURITIES/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GARLIC PF 40(5) Pg. ONLINE CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED GARLIC PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method I <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GEMFIBROZIL TABLETS PF 40(4) Pg. ONLINE
IDENTIFICATION/Procedure, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities
Sujatha Ramakrishna
Revision GINGER PF 40(5) Pg. ONLINE CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561> Anton Bzhelyansky
Revision POWDERED GINGER PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GINKGO PF 40(5) Pg. ONLINE
DEFINITION/Introduction, COMPOSITION/Content of Flavonol Glycosides, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GOLDENSEAL PF 40(5) Pg. ONLINE COMPOSITION/Content of Berberine and Hydrastine and Limit of Palmatine, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED GOLDENSEAL PF 40(5) Pg. ONLINE
COMPOSITION/Content of Berberine and Hydrastine and Limit of Palmatine, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GONADORELIN HYDROCHLORIDE PF 40(4) Pg. ONLINE
Chemical Info/C55H75N17O13 · 2×HCl, Chemical Info/1255.211182.30
(free base), Chemical Info/Gonadorelin dihydrochloridehydrochloride;, Chemical Info/5-Oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosylglycyl-l-leucyl-l-arginyl-l-prolylglycinamide dihydrochloridehydrochloride salt, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. HPLC, ASSAY/Procedure, IMPURITIES/Gonadorelin Related Impurities, IMPURITIES/Limit of Acetate, IMPURITIES/Acetic Acids in Peptides <503>, IMPURITIES/Limit of Trifluoroacetic Acid, IMPURITIES/Limit of Fluoride, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Water Determination, SPECIFIC TESTS/Water Determination, Method I <921>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gonadorelin Related Compound A RS
Chensheng Li
Revision GONADORELIN FOR INJECTION PF 40(5) Pg. ONLINE
IDENTIFICATION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/Bacterial Endotoxins Test <85>
Chensheng Li
Revision GRAFTSKIN PF 40(5) Pg. ONLINE {Title} Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold, DEFINITION/Introduction, SPECIFIC TESTS/Histological
Rebecca Potts
Characterization, SPECIFIC TESTS/Gene Expression Profile, SPECIFIC TESTS/Barrier Integrity Assessment, SPECIFIC TESTS/Metabolic Activity Assessment, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards, Authentic Visual References <11>
Omission GUANADREL SULFATE PF 40(5) Pg. ONLINE
Entire document Sujatha Ramakrishna
Omission GUANADREL SULFATE TABLETS PF 40(5) Pg. ONLINE
Entire document Sujatha Ramakrishna
Revision GUGGUL PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision GYMNEMA PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED GYMNEMA PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561>
Anton Bzhelyansky
Revision HALOBETASOL PROPIONATE PF 40(2) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities Hillary Cai
Revision HAWTHORN LEAF WITH FLOWER PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED HAWTHORN LEAF WITH FLOWER PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>,
CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS PF 40(4) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dihydrocodeine Bitartrate, Hydrocodone Diol, and Related Substances, IMPURITIES/Limit of Homatropine Hydrobromide and Related Substances
Hillary Cai
Revision HYPROMELLOSE Stage 6 Harmonization Entire Document Jenny Liu
New IMINODIACETIC ACID PF 40(4) Pg. ONLINE
Iminodiacetic Acid, Margareth Marques
Revision INSULIN HUMAN PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B. Peptide Mapping, IDENTIFICATION/B. Physicochemical Analytical Procedures for Insulins, Peptide Mapping <121.1>, Related Substances, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins, Limit of High Molecular Weight Proteins <121.1>, Single-Chain Precursor Content, Host Cell Protein, ADDITIONAL REQUIREMENTS/Labeling
Mary Crivellone
Revision INSULIN HUMAN INJECTION PF 40(5) Pg. ONLINE
Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins, Limit of High Molecular Weight Proteins <121.1>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Insulin (Pork) RS
Mary Crivellone
Revision ISOPHANE INSULIN HUMAN SUSPENSION PF 40(5) Pg. ONLINE
ASSAY/Procedure, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins, Limit of High Molecular Weight Proteins <121.1>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Insulin (Pork) RS
Edith Chang
Revision HUMAN INSULIN ISOPHANE SUSPENSION AND HUMAN INSULIN INJECTION PF 40(5) Pg. ONLINE
Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins, Limit of High Molecular Weight Proteins <121.1>, SPECIFIC TESTS/Soluble Insulin Human Content, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Labeling
Edith Chang
Omission INSULIN HUMAN ZINC SUSPENSION PF 40(5) Pg. ONLINE
Entire document Mary Crivellone
Omission EXTENDED INSULIN HUMAN ZINC SUSPENSION PF 40(5) Pg. ONLINE
Entire document Mary Crivellone
Revision INSULIN LISPRO PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/B. Peptide Mapping, IDENTIFICATION/B. Physicochemical Analytical Procedures for Insulins, Peptide Mapping <121.1>, Limit of High Molecular Weight Proteins, Physicochemical Analytical Procedures for Insulins, Limit of High Molecular Weight Proteins <121.1>, Single-Chain Precursor Content, Host Cell Protein, ADDITIONAL REQUIREMENTS/Labeling
Mary Crivellone
Revision INSULIN LISPRO INJECTION PF 40(5) Pg. ONLINE
Limit of High Molecular Weight Proteins, Physicochemical Analytical
Procedures for Insulins, Limit of High Molecular Weight Proteins <121.1>, ADDITIONAL REQUIREMENTS/Labeling
Mary Crivellone
Revision IRON DEXTRAN INJECTION PF 40(4) Pg. ONLINE
SPECIFIC TESTS/Acute Toxicity Sujatha Ramakrishna
New IRON (POWDER) PF 40(4) Pg. ONLINE Iron (Powder), Margareth Marques
Revision ISOFLURANE PF 40(4) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, IMPURITIES/Limit of Fluoride, IMPURITIES/Nonvolatile Residue, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acetone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isoflurane Related Compound A RS
Mary Koleck
Revision ISOPROPYL PALMITATE PF 40(4) Pg. ONLINE
ASSAY/Procedure Galina Holloway
Revision KETOCONAZOLE PF 40(4) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terconazole RS
Shankari Shivaprasad
New L86 PF 40(2) Pg. ONLINE L86 Margareth Marques
Revision LACTULOSE CONCENTRATE PF 40(5) Pg. ONLINE
Chemical Info/Chemical Name, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Refractive Index <831>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tagatose RS
Elena Gonikberg
Revision LACTULOSE SOLUTION PF 40(5) Pg. ONLINE
IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tagatose RS
Elena Gonikberg
New LAMIVUDINE TABLETS PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lamivudine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lamivudine Resolution Mixture B RS
Shankari Shivaprasad
New LAMOTRIGINE EXTENDED-RELEASE TABLETS PF 40(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lamotrigine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lamotrigine Related Compound C RS
Ravi Ravichandran
New LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS PF 40(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage
Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlorobenzhydryl Piperazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Levocetirizine Dihydrochloride RS
Mary Koleck
Revision LICORICE PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED LICORICE PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision LOPERAMIDE HYDROCHLORIDE TABLETS PF 40(2) Pg. ONLINE
IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Loperamide Related Compound F RS
Elena Gonikberg
New LOPINAVIR AND RITONAVIR ORAL SOLUTION PF 40(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Lopinavir and Ritonavir, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Alcohol Determination
Shankari Shivaprasad
<611>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lopinavir RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ritonavir RS
Omission LYPRESSIN NASAL SOLUTION PF 40(5) Pg. ONLINE
Entire document Anita Szajek
Revision MAGNESIUM SALICYLATE PF 40(1) Pg. ONLINE
C14H10MgO6, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/Ultraviolet Absorption <197U>, ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound B RS
Hillary Cai
Revision MAGNESIUM SALICYLATE TABLETS PF 40(4) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid Related Compound B RS
Hillary Cai
Revision MALABAR-NUT-TREE, LEAF PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED MALABAR-NUT-TREE, LEAF PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
New MANGANESE PF 40(4) Pg. ONLINE Manganese, Margareth Marques
Revision MANGANESE GLUCONATE PF 40(5) Pg. ONLINE
IMPURITIES/Lead Huy Dinh
New MARBOFLOXACIN COMPOUNDED ORAL SUSPENSION, VETERINARY PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling
Jeanne Sun
Revision MERCAPTOPURINE PF 40(5) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Didanosine Related Compound A RS Hypoxanthine.C5H4N4O136.11
Feiwen Mao
Revision METHIMAZOLE PF 40(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities <466>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methimazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methimazole Related
Elena Gonikberg
Compound C RS
Revision METHYL SALICYLATE PF 40(2) Pg. ONLINE
IDENTIFICATION/B. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Limit of Salicylic Acid and Dimethyl 4-Hydroxyisophthalate, SPECIFIC TESTS/Refractive Index <831>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Salicylate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Salicylic Acid RS
Galina Holloway
Revision METHYLCELLULOSE Stage 6 Harmonization
Entire Document Jenny Liu
Revision METHYLTESTOSTERONE PF 40(5) Pg. ONLINE
IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>
Mary Koleck
Revision MILK THISTLE PF 40(5) Pg. ONLINE COMPOSITION/Content of Silymarin, CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED MILK THISTLE PF 40(5) Pg. ONLINE
COMPOSITION/Content of Silymarin, CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision MINERALS CAPSULES PF 40(5) Pg. ONLINE
SPECIFIC TESTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision MINERALS TABLETS PF 40(5) Pg. ONLINE
SPECIFIC TESTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision MYCOPHENOLATE MOFETIL CAPSULES
PF 40(5) Pg. ONLINE DEFINITION/Introduction, ASSAY/Procedure Feiwen Mao
Revision MYCOPHENOLATE MOFETIL TABLETS PF 40(5) Pg. ONLINE
DEFINITION/Introduction, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>
Feiwen Mao
Revision MYRISTYL ALCOHOL PF 40(1) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Related Fatty Alcohols, SPECIFIC TESTS/Melting Range or Temperature, Class II <741>, SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauryl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Stearyl Alcohol RS
Galina Holloway
Revision MYRRH PF 40(5) Pg. ONLINE IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Elemental Impurities <561>
Nam-Cheol Kim
Revision NADOLOL PF 40(4) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities
Sujatha Ramakrishna
Revision NICOTINE PF 40(2) Pg. ONLINE
IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/A. Infrared Absorption <197F>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound G RS
Ravi Ravichandran
Revision NICOTINE POLACRILEX PF 40(2) Pg. ONLINE
Chemical Info/Chemical Name[(C4H6O2)x(C10H10)y](C10H14N2) 2-Propenoic acid, 2-methyl-, polymer with diethenylbenzene, complex with (S)-3-(1-methyl-2-pyrrolidinyl)pyridine; Methacrylic acid polymer with divinylbenzene, complex with nicotine 96055-45-7 Chemical Info/CAS, IDENTIFICATION/B. Infrared Absorption <197K>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related
Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nicotine Related Compound G RS
Ravi Ravichandran
New NORTHERN SCHISANDRA FRUIT PF 40(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Botanic Characteristics, IDENTIFICATION/B. Thin-Layer Chromatography, IDENTIFICATION/C. HPLC, COMPOSITION/Content of Lignans, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, CONTAMINANTS/Articles of Botanical Origin, Aflatoxins <561>, SPECIFIC TESTS/Botanic Characteristics, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin, Total Ash <561>, SPECIFIC TESTS/Articles of Botanical Origin, Water-Soluble Extractives <561>, SPECIFIC TESTS/Articles of Botanical Origin, Alcohol-Soluble Extractives <561>, SPECIFIC TESTS/Articles of Botanical Origin, Foreign Organic Matter <561>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Schisandra chinensis Fruit Dry Extract RS,
Christopher Okunji
ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Schisandrin RS
New NORTHERN SCHISANDRA FRUIT POWDER PF 40(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Lignans, CONTAMINANTS/Elemental Impurities-Procedures <233>, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, CONTAMINANTS/Articles of Botanical Origin, Test for Aflatoxins <561>, SPECIFIC TESTS/Botanic Characteristics, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin, Total Ash <561>, SPECIFIC TESTS/Articles of Botanical Origin, Water-Soluble Extractives <561>, SPECIFIC TESTS/Articles of Botanical Origin, Alcohol-Soluble Extractives <561>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Schisandra chinensis Fruit Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Schisandrin RS
Christopher Okunji
Revision OCTYLDODECANOL PF 40(2) Pg. ONLINE
Chemical Info, DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Related Fatty Alcohols, SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401>, SPECIFIC TESTS/Fats and Fixed Oils, Saponification Value <401>, SPECIFIC TESTS/Water
Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Capric Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cetyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linoleyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleyl Alcohol RS
Galina Holloway
Revision OLEYL ALCOHOL PF 40(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Related Fatty Alcohols, SPECIFIC TESTS/Cloud Point, SPECIFIC TESTS/Refractive Index <831>, SPECIFIC TESTS/Fats and Fixed Oils, Iodine Value <401>, SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401>, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Galina Holloway
Revision OLIVE OIL PF 40(4) Pg. ONLINE
IDENTIFICATION/B. Identity by Triglyceride Profile, SPECIFIC TESTS/Absorbance, SPECIFIC TESTS/Fats and Fixed Oils, Sterol Composition <401>, SPECIFIC TESTS/Sterol Composition, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Hong Wang
Revision OMEGA-3 ACIDS TRIGLYCERIDES PF 40(5) Pg. ONLINE
CONTAMINANTS/Limit of Lead Huy Dinh
New 1-PENTADECANOL PF 40(2) Pg. ONLINE
1-Pentadecanol Margareth Marques
Revision PHENYLEPHRINE BITARTRATE PF 40(2) Pg. ONLINE
Chemical Info/Chemical Name Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]- , (2R,3R)-2,3-dihydroxybutanedioate (1:1) (salt); (R)-(-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrogen tartrate, DEFINITION/Introduction, IDENTIFICATION/B. Identification Tests-General, Tartrate <191>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation <781S>, Specific Rotation, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norphenylephrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound E RS
Hillary Cai
Revision PHENYLEPHRINE HYDROCHLORIDE PF 40(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/C., ASSAY/Procedure, OTHER COMPONENTS/Content of Chloride, IMPURITIES/Limit of Ketones, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norphenylephrine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine
Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenylephrine Related Compound E RS
Hillary Cai
Omission PHENYLPROPANOLAMINE BITARTRATE PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Revision PHENYLPROPANOLAMINE HYDROCHLORIDE PF 40(5) Pg. ONLINE
ADDITIONAL REQUIREMENTS/Labeling Hillary Cai
Omission PHENYLPROPANOLAMINE HYDROCHLORIDE CAPSULES PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Omission PHENYLPROPANOLAMINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Omission PHENYLPROPANOLAMINE HYDROCHLORIDE ORAL SOLUTION PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Omission PHENYLPROPANOLAMINE HYDROCHLORIDE TABLETS PF 40(5)
Entire document Hillary Cai
Pg. ONLINE
Omission PHENYLPROPANOLAMINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PF 40(5) Pg. ONLINE
Entire document Hillary Cai
Revision PHENYTOIN PF 40(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of benzophenone, SPECIFIC TESTS/Clarity and Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenytoin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Phenytoin Related Compound B RS
Ravi Ravichandran
Revision PHYLLANTHUS AMARUS PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED PHYLLANTHUS AMARUS PF 40(5) Pg. ONLINE
CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
New PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES PF 40(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, IMPURITIES/Content of Propafenone Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP
Reference Standards <11>/USP Propafenone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propafenone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propafenone Related Compound B RS
Sujatha Ramakrishna
Revision PSYLLIUM HUSK PF 40(5) Pg. ONLINE IMPURITIES/Heavy Metals, Method II <231>, IMPURITIES/Articles of Botanical Origin, Elemental Impurities <561>
Nam-Cheol Kim
Revision PYGEUM PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision RITONAVIR ORAL SOLUTION PF 40(4) Pg. ONLINE
ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Alcohol Content, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Alcohol Determination-Alcohol RS
Shankari Shivaprasad
New RIZATRIPTAN BENZOATE TABLETS PF 40(4) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rizatriptan Benzoate RS
Ravi Ravichandran
New RIZATRIPTAN BENZOATE ORALLY DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, Ravi Ravichandran
DISINTEGRATING TABLETS PF 40(4) Pg. ONLINE
PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rizatriptan Benzoate RS
Revision ST. JOHN'S WORT PF 40(5) Pg. ONLINE CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED ST. JOHN'S WORT PF 40(5) Pg. ONLINE
COMPOSITION/Content of Hypericin and Pseudohypericin, CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision SAW PALMETTO PF 40(5) Pg. ONLINE DEFINITION/Introduction, COMPOSITION/Content of Fatty Acids, CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
Revision POWDERED SAW PALMETTO PF 40(5) Pg. ONLINE
DEFINITION/Introduction, COMPOSITION/Content of Fatty Acids, CONTAMINANTS/Heavy Metals <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>
Anton Bzhelyansky
New SCAFFOLD PORCINE BLADDER PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/Note, IDENTIFICATION/A. Immunohistochemistry for Type IV Collagen, IDENTIFICATION/B. Periodic Acid-Schiff Stain for Basement Membrane Structure, SPECIFIC TESTS/Tensile Strength of Sheet Forms, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/ Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference
Standards <11>/USP Endotoxin RS
Maura Kibbey
New SCAFFOLD SILK FIBROIN PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IMPURITIES/Nonpolar Solvent Extraction, IMPURITIES/Elemental Impurities-Limits <232> and Elemental Impurities-Procedures <233>, SPECIFIC TESTS/Fibroin Content, SPECIFIC TESTS/Dimensional Analysis, SPECIFIC TESTS/Density Determination, SPECIFIC TESTS/Pore Characterization, SPECIFIC TESTS/Ball Burst Testing, SPECIFIC TESTS/Tensile Testing, SPECIFIC TESTS/Suture Retention Force, SPECIFIC TESTS/Tear Testing, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS
Rebecca Potts
Revision SCHIZOCHYTRIUM OIL PF 40(5) Pg. ONLINE
IMPURITIES/Inorganic Impurities, IMPURITIES/Limit of Lead Huy Dinh
Revision SCHIZOCHYTRIUM OIL CAPSULES PF 40(5) Pg. ONLINE
IMPURITIES/Limit of Lead Natalia Davydova
Revision SENNOSIDES PF 40(5) Pg. ONLINE COMPOSITION/Procedure, COMPOSITION/Content of Sennosides A and B, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP
Nam-Cheol Kim
Sennoside A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sennoside B RS
Revision SERTRALINE HYDROCHLORIDE TABLETS PF 40(4) Pg. ONLINE
IMPURITIES/Organic Impurities Ravi Ravichandran
Revision SODIUM CHLORIDE Stage 6 Harmonization
Entire Document Jenny Liu
Revision SOYBEAN OIL PF 40(4) Pg. ONLINE
IDENTIFICATION/B. Identity by Triglyceride Profile, SPECIFIC TESTS/Fats and Fixed Oils, Sterol Composition <401>, SPECIFIC TESTS/Sterol Composition, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>
Hong Wang
New SPIRULINA PF 37(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Fatty Acids Profile, IDENTIFICATION/C. HPLC for Chlorophyll A, IDENTIFICATION/D. HPLC for Carotenoids, COMPOSITION/Content of Beta Carotene and Total Carotenoids, COMPOSITION/Content of C-Phycocyanin, COMPOSITION/Content of Protein, CONTAMINANTS/Limit of Microcystins, CONTAMINANTS/Elemental Contaminants, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, SPECIFIC TESTS/Description, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin, Total Ash <561>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference
Standards <11>/USP Beta Carotene RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Linoleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Linolenate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Oleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Palmitate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Palmitoleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Stearate RS
Anton Bzhelyansky
New SPIRULINA TABLETS PF 37(6) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/A. Fatty Acids Profile, IDENTIFICATION/B. HPLC for Chlorophyll A, IDENTIFICATION/C. HPLC for Carotenoids, STRENGTH/Content of Beta Carotene and Total Carotenoids, STRENGTH/Content of C-Phycocyanin, STRENGTH/Content of Protein, PERFORMANCE TESTS/Weight Variation <2091>, CONTAMINANTS/Limit of Microcystins, CONTAMINANTS/Elemental Contaminants <2233>, CONTAMINANTS/Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Beta Carotene RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Linoleate RS, ADDITIONAL
Anton Bzhelyansky
REQUIREMENTS/USP Reference Standards <11>/USP Methyl Linolenate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Oleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Palmitate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Palmitoleate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Methyl Stearate RS
Revision STEARYL ALCOHOL PF 40(2) Pg. ONLINE
Chemical Info/C18H38O, Chemical Info/270.49, DEFINITION/Introduction, IDENTIFICATION/A. Chromatographic Identity, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Related Fatty Alcohols, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401>, SPECIFIC TESTS/Water Determination, Method I <921>, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Arachidyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lauryl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Linolenyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Myristyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oleyl Alcohol RS
Galina Holloway
Revision THIMEROSAL PF 40(5) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Ether-Soluble Substances, IMPURITIES/Readily Carbonizable Substances Test <271>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Thimerosal Related
Compound A RS
Shankari Shivaprasad
Revision TIMOLOL MALEATE PF 40(2) Pg. ONLINE
DEFINITION/Introduction, IDENTIFICATION/C., ASSAY/Titrimetry <541>, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Timolol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Timolol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Timolol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Timolol Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Timolol Related Compound F RS
Sujatha Ramakrishna
New TOLTERODINE TARTRATE PF 40(2) Pg. ONLINE
Chemical Info/Chemical Structure, Chemical Info/C22H31NO·C4H6O6, Chemical Info/475.57, Chemical Info/(R)-2-[3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol (2R,3R)-2,3-dihydroxybutanedioate (1:1) (salt);, Chemical Info/(+)-(R)-2-[α-[2-(Diisopropylamino)ethyl]benzyl]-p-cresol l-tartrate (1:1) (salt);, Chemical Info/(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol tartrate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL
Elena Gonikberg
REQUIREMENTS/USP Reference Standards <11>/USP Tolterodine S-Enantiomer RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tolterodine System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tolterodine Tartrate RS
Revision TREHALOSE PF 40(5) Pg. ONLINE SPECIFIC TESTS/Nitrogen Determination, Method IMethod II <461> Galina Holloway
Revision TURMERIC PF 40(5) Pg. ONLINE
COMPOSITION/Content of Curcuminoids, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>, SPECIFIC TESTS/Water Determination, Method 1a <921>
Anton Bzhelyansky
Revision POWDERED TURMERIC PF 40(5) Pg. ONLINE
DEFINITION/Introduction, COMPOSITION/Content of Curcuminoids, CONTAMINANTS/Heavy Metals, Method III <231>, CONTAMINANTS/Articles of Botanical Origin, Limits of Elemental Impurities <561>, SPECIFIC TESTS/Water Determination, Method Ia <921>
Anton Bzhelyansky
Revision OIL-SOLUBLE VITAMINS CAPSULES PF 40(5) Pg. ONLINE
CONTAMINANTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision OIL-SOLUBLE VITAMINS TABLETS PF 40(5) Pg. ONLINE
CONTAMINANTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision OIL-SOLUBLE VITAMINS WITH MINERALS CAPSULES PF 40(5) Pg. ONLINE
CONTAMINANTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision OIL-SOLUBLE VITAMINS WITH MINERALS TABLETS PF 40(5) Pg.
ONLINE
CONTAMINANTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision WATER-SOLUBLE VITAMINS WITH MINERALS ORAL SOLUTION PF 40(5) Pg. ONLINE
CONTAMINANTS/Absence of Specified Microorganisms <2022> Natalia Davydova
Revision WHEAT BRAN PF 40(5) Pg. ONLINE CONTAMINANTS/Heavy Metals, Method II <231>, CONTAMINANTS/Article of Botanical Origin, Elemental Impurities <561>
Nam-Cheol Kim
Revision SMALL INTESTINAL SUBMUCOSA WOUND MATRIX PF 40(5) Pg. ONLINE
{Title} Scaffold Porcine Small Intestinal Submucosa, DEFINITION/Introduction, SPECIFIC TESTS/Fibroblast Growth Factor-2 Content, SPECIFIC TESTS/Glycosaminoglycan Content, SPECIFIC TESTS/Bioactivity, SPECIFIC TESTS/Metabolic Activity Assessment, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Labeling
Rebecca Potts
Revision ZEIN PF 40(5) Pg. ONLINE IDENTIFICATION/C. Identification of alpha-Zein bySDS-Polyacrylamide Gel Electrophoresis, IDENTIFICATION/C. Identification of alpha-Zein bySDS-Polyacrylamide Gel Electrophoresis
Hong Wang
Revision ZINC GLUCONATE PF 40(5) Pg. ONLINE IMPURITIES/Limit of Lead Huy Dinh